MAUDE Adverse Event Report: VERAN MEDICAL TECHNOLOGIES, INC. ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH; BIOPSY BRUSH

Model Number	INS-5300
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was discarded by the hospital.Based on the complaint details, the investigation determined that the potential failure modes could include damage to the pull wires, or incorrect lengths of the pull wires/sheath that caused actuation to not force the needle back in.However, a definitive root cause could not be determined, since the device was not returned.Veran will continue to monitor field performance for this device.This event is being reported as a corrective action following a retrospective review of complaints in response to an observation from an external inspection.
Event or Problem Description
The user facility reported that when the technician took the ins-5300 (always-on tip tracked triple needle brush) out of the clear plastic circle, the brush was deployed out of the sheath.When the technician fully retracted the brush, the needles were still out.When the technician held each end of the instrument and pulled apart gently, this allowed the tip to sit properly inside the sheath.The staff had to do this multiple times.The intended procedure was able to be completed using the subject device.There was no patient or user injury due to the reported issue.This report is being submitted for the needles not retracting.

• Brand Name: ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH
• Common Device Name: BIOPSY BRUSH
• Manufacturer (Section D): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer (Section G): VERAN MEDICAL TECHNOLOGIES, INC.; 1938 innerbelt business center; saint louis MO 63114
• Manufacturer Contact: jennifer andre ; 1938 innerbelt business center; saint louis, MO 63114 ; 3146598500
• MDR Report Key: 17210745
• Report Number: 3007222345-2023-00038
• Device Sequence Number: 15119989
• Product Code: JAK
• UDI-Device Identifier: 00815686021207
• UDI-Public: 00815686021207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K170023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2023
• Device Model Number: INS-5300
• Device Catalogue Number: INS-5300
• Device Lot Number: 04617200717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown